Standard Operating Procedure for Cleaning and Sanitization of FFS Machine

1) Purpose

The purpose of this SOP is to define the procedure for cleaning and sanitizing the Form-Fill-Seal (FFS) machine to prevent cross-contamination, ensure product quality, and comply with regulatory requirements.

2) Scope

This SOP applies to the cleaning and sanitization of all FFS machines used in pharmaceutical manufacturing processes within the facility.

3) Responsibilities

3.1 Production Operators
– Perform cleaning and sanitization tasks on FFS machines following established procedures.
– Ensure all cleaning materials and equipment are used and stored properly.
3.2 Cleaning Validation Team
– Validate cleaning procedures to ensure effectiveness in removing residues and contaminants.
– Document and report validation findings to Quality Assurance (QA).
3.3 Quality Assurance (QA) Personnel
– Review and approve cleaning procedures and validation reports.
– Conduct periodic audits to verify compliance with SOPs and regulatory standards.

4) Procedure

4.1 Pre-Cleaning Preparation
4.1.1 Power off and isolate the FFS machine from power sources and production areas.
4.1.2 Disassemble removable parts and components for thorough cleaning.
4.2 Cleaning Process
4.2.1 Remove visible residues and contaminants using appropriate cleaning agents and tools.
4.2.2 Rinse surfaces with clean water to remove cleaning agents and residues.
4.3 Sanitization
4.3.1 Apply a suitable sanitizing agent to all surfaces of the FFS machine.
4.3.2 Allow sufficient contact time as per manufacturer’s instructions for effective sanitization.
4.4 Inspection and Verification
4.4.1 Inspect cleaned and sanitized components for cleanliness and absence of residues.
4.4.2 Verify effectiveness of cleaning by conducting swab or rinse sampling as per validated procedures.
4.5 Reassembly and Final Checks
4.5.1 Reassemble cleaned components of the FFS machine in accordance with assembly diagrams and procedures.
4.5.2 Perform final checks to ensure all parts are properly installed and functioning.

5) Abbreviations, if any

– FFS: Form-Fill-Seal
– QA: Quality Assurance

6) Documents, if any

– Cleaning and Sanitization Log
– Cleaning Validation Report
– Swab Sampling Records

7) Reference, if any

– USP General Chapter <1072> Disinfectants and Antiseptics
– ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness

8) SOP Version

Version 1.0